PROCESS FOR THE PRODUCTION OF AN ABUSE-PROOFED DOSAGE FORM

摘要

The present invention relates to a process for the production of an abuse-proofed dosage form containing, apart from one or more active ingredients with potential for abuse and optionally physiologically acceptable auxiliary substances, at least one synthetic or natural polymer (C) with a breaking strength of at least 500 N, wherein the formulation mixture is combined with a solvent for the polymer (C) at least in quantities such that the formulation mixture is at least uniformly moistened, the at least moistened composition is optionally divided into sub-portions, dried and shaped to yield the dosage form.

主权项

1. A process for the production of a solid dosage form with at least reduced potential for abuse, said dosage form exhibiting a breaking strength of at least 500 N, said process comprising:
a) providing a formulation mixture comprising at least one active ingredient with potential for abuse (A) and at least one synthetic or natural polymer (C), wherein the at least one active ingredient with potential for abuse (A) is selected from the group consisting of oxymorphone and physiologically acceptable compounds and derivatives thereof, b) moistening the mixture with at least a sufficient quantity of a solvent for the polymer (C) to uniformly moisten the mixture, c) optionally dividing the mixture from step b) into sub-portions, d) drying the sub-portion(s) from step c) or the mixture from step b) and e) shaping the dried sub-portion or mixture from step d) to yield the dosage form.